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botiss biomaterials bone & tissue regeneration max graft ® max graft ® bonering max graft ® bonebuilder max graft ® cortico Processed human allograft hard tissue safe biologic successful

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Page 1: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

1

botissbiomaterials

bone & tissue regeneration

maxgraft®

maxgraft® boneringmaxgraft® bonebuildermaxgraft® corticoProcessed human allograft

hard

tiss

ue

safe

biologic

successful

Page 2: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

2 3

Processed human allograftIntroduction

Various bone graft materials are available to replace and regenerate

bone matrix lost by tooth extraction, cystectomy or bone atrophy

followed by loss of teeth or inflammatory processes.

Of all grafting options autologous bone is considered the „gold

standard“, because of its biological activity due to vital cells and

growth factors.

Yet, the autologous bone from intra-oral donor sites is of restricted

quantity and availability1. The bone tissue obtained from the iliac

crest is described to be subject to fast resorption2. Moreover, the

harvesting of autologous bone requires a second surgical site

associated with an additional bone defect and potential donor site

morbidity. Thus, application of processed allogenic bone tissue

represents a suitable alternative.

New bone formation after grafting with allogenic bone tissue begins

with an acute inflammatory response, within which granulation

tissue gradually accumulates, and by activation of osteoclasts.

Subsequently the incorporation process begins with the vasculariza-

tion of the allograft. By activation of osteoclasts the immune system

facilitates the remodeling of the graft. These large cells completely

degrade medullary bone, thereby allowing its substitution by osteo-

blasts. The immunological compatibility of processed allogenic

bone is not different from autologous tissue. No circulating

antibodies could be detected in blood samples from patients

that underwent allograft surgery³. Moreover, several histological

and morphological studies have well documented that there was

clinically no difference in the final stage of incorporation between

allograft and autologous graft4,5,6.

1. Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208.2. Dragoo MR, Irwin RK.A method of procuring cancellous iliac bone utilizing a trephine needle. Periodontol. 1972 Feb;43(2):82-7.3. Gomes KU, Carlini JL, Biron C, Rapoport A, Dedivitis RA. Use of allogeneic bone graft in maxillary reconstruction for installation of dental implants. J Oral Maxillofac Surg. 2008 Nov;66(11):2335-8.4. Urist MR. Bone: Formation by autoinduction. Science 150:893, 19655. Urist MR: Bone morphogenetic protein induced bone formation in experimental animals and patients with large bone defects, in Evered D, Barnett S (eds): Cell and Molecular Biology of Vertebrate Hard Tissue. London, CIBA Foundation, 19886. Schlee et al.. Esthetic outcome of implant-based reconstructions in augmented bone: comparison of autologous and allogeneic bone block grafting with the pink esthetic score (PES). Head Face Med. 2014 May 28;10(1):21. doi: 10.1186/1746-160X-10-21.

ClassificationAutologous: - Patient‘s own bone, mostly

harvested intra-oraly or from

the iliac crest

- Intrinsic biological activity

Allogenic: - Bone from human donors

(multi-organ donors or femoral

heads of living donors)

- Natural bone composition and

structure

Xenogenic: - From other organisms, mainly

bovine origin

- Long-term volume stability

Alloplastic: - Synthetically produced, pre-

ferably calcium phosphate

ceramics

- No risk of disease transmission

bone

osteoclast

Regeneration

Controlled D

egradationBio

logi

cal P

oten

tial

High Quality Learning

* Coming soon

Development / Production / Distribution

Augmentation

mucoderm®

collprotect® membrane

Jason® membrane

Jason® fleece

collacone®......

collacone®..max

hard tissue

cerabone®

maxresorb®

maxresorb®

inject

maxgraft® bonebuildermaxgraft® cortico

maxgraft® boneringmaxgraft®

EDUCATION

SCIENCE CLINIC

Fast Regeneration

Preservation

OsseousIntegration Remodeling

Healing

BarrierResorption

maxresorb® flexbone*

soft tissue

botiss academy bone & tissue days

cerabone®

Natural bovine bone graft

maxresorb® inject maxgraft® bonering / maxgraft® cortico

maxgraft®

bonebuilder

Patient matched allogenic bone implant

Synthetic injectable bone paste

maxresorb®

Synthetic biphasic calcium phosphate

Allogenic bone ring / Processed allogenic bone plate

maxresorb® flexbone*

Flexible block (CaP / Collagen composite)

mucoderm®

3D-stable soft tissue (Collagen) graft

Jason® membrane

Native pericardium GBR / GTR membrane

collprotect® membrane

Native collagen membrane

Jason® fleece /collacone®

collacone® max

Collagenic haemostat (Sponge / Cone)

Alveolar cone(CaP / Collagen composite)

maxgraft®

Processed allogenic bone graft

Page 3: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

4 5

Cells+Tissuebank Austria

C+TBA is a non-profit organization aiming to maintain continuous

medical supply of allografts under pharmaceutical conditions.

Serving as a platform for the definition of safety standards and assu-

rance of compliance with defined product qualities, C+TBA focuses

on the specifications of human bone tissue as required in a large

number of diseases that are associated with the loss of bone tissue.

To meet and comply with both European and national requirements, C+TBA has

implemented a quality assurance system at pharmaceutical level, which is regularly

audited by the competent national authority, the Austrian Federal Office for Safety in

Health Care (BASG / AGES).

The C+TBA is certified as a tissue bank according to §19 and §22 of the Austrian

Tissue Safety Act.

Donor tissue is only approved for processing after having passed a thorough inspection including a strict serological screening protocol

Blood samples are taken simultaneously to tissue explanta-tion during total hip replacement surgery or within 24h post mortem in case of multi-organ donation

.................................................

......................

Tissue donation and procurement

maxgraft® products are predominantly produced from living donor

femoral heads after hip replacement surgery. Only cortico-

cancellous blocks and cortical struts are produced from multi-organ

donors.

The procurement, standardized by a predefined protocol, is carried

out by certified procurement centers according to the European

Directives. Tissue donations will only be carried out after the donor‘s

written consent. In addition, the health status of the potential donor

is assessed in the context of a risk analysis and the donor is then

selected on the basis of strict exclusion criteria. For all multi-organ

donors the highest ethical and safety-related requirements are met.

After donor acceptance a series of serological tes-

ting is performed. In addition to antibody scree-

ning (Ab), nucleic acid tests (NAT) are performed.

By using this method infections can be identified

before antibodies are detected in the blood.

Serological testing

Virus Test Specification

Hepatitis B Virus (HBV) HBsAg,HBcAb, NAT negative

Hepatitis C Virus (HCV) Ab, NAT negative

Human Immunodeficiency Virus (HIV 1/2) Ab, NAT negative

Bacteria Test Specification

Treponema pallidum (Lues) CMIA negative

Kremsthe Danube

A

DE

CZ

SK

HU

CHIT

The quality standards for donor selection, procurement, processing, quality control, storage and dis-

tribution of human tissue and cells are mandatory committed in the European Directives 2004/23/EC

and 2006/17/EC. In addition, at the national level, the legal requirements are defined by the Austrian

Tissue Safety Act (GSG, 2009).

Page 4: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

6 7

Safety and quality

Thorough donor anamnesis and serological testing combined

with chemical and radiological sterilization offer maximal safety.

The critical viral inactivation steps of the process – dynamic immer-

sion in ethanol, hydrogen peroxide and gamma irradiation – have

been validated for reliability and reproducibility by an independent

test facility. Suspensions of model viruses for non-enveloped

and enveloped DNA viruses (HBV), and non-enveloped (HAV) and

enveloped RNA viruses (HIV, HCV, HTLV) have been applied. The

process shows an overall efficacy in inactivating all test viruses glo-

bally > 6 logs (reference value for efficient viral inactivation > 4 logs)

and therefore can be considered effective in removing potential viral

contaminants.

Biomechanical properties have recently been analyzed by the Institute of Material

Science of the Technical University of Vienna, Austria. After the determination of E-

modulus and pressure resistance no significant alterations were detected in irradiated

products (post rad.) compared to non-irradiated ones (post proc.).

Samples are stored one year after the expiration

date of the products, in order to be able to exclu-

de maxgraft® as a source of transmission in case

of a doubt. Despite worldwide monitoring, there

is no single case of the transmission of a disease,

caused by allografts used in dental medicine.

Reference samples

15

10

5

0post rad. post proc.

pre

ssur

e re

sist

ance

R

m [M

Pa]

0.0 0.5 1.0 1.5 2.0

specific E-Modulus E/ρ [MPa m3/kg]

In an extensive experimental setting virus inactivating capacity of the process was validated and considered effective

.................................................

C+TBA‘s allograft products provide a stable scaffold for revascularization and osteoblast migration. Simultaneously, due to the preserved collagen content, the graft presents high flexibility supporting physiological bone formation and remodelling

Virus inactivation

The C+TBA cleaning process

Step 1:After crude removal of surrounding soft tissue, fat and cartilage, the donor tissue is brought into its final shape.

After shaping and crude cleaning, the donor

tissue undergoes ultrasonication to remove

blood, cells and tissue components, but mainly

to promote the removal of fat from the can-

cellous structure of the bone, improving the

penetration of subsequent substances.

During a chemical treatment non-collagenic proteins are denatured,

potential viruses are inactivated and bacteria are destroyed.

In the subsequent oxidative treatment, persisting soluble proteins

are denatured and potential antigenicity is eliminated.

Finally, the tissue undergoes lyophilization, a de-

hydration technique which facilitates the sublima-

tion of frozen tissue water from solid phase to gas

phase, thereby preserving the structural integrity

of the material.

The tissue can be reconstituted rapidly due to microscopic pores

within the material, which were created by the sublimating ice

crystals during lyophilization. It has been well established that the

lyophilization process preserves structural properties that improve

graft incorporation7.

The final sterilization by gamma irradiation guarantees a sterility as-

surance level (SAL) of 10-6 while ensuring structural and functional

integrity of the product and its packaging.

Step 2:The defatting of the donor tissue allows penetration of solvents during subsequent processing.

Step 3:A treatment with alterna-ting durations of diethyl ether and ethanol lea-ches out cellular com-ponents and denatures non-collagenic proteins, thereby inactivating potential viruses.

Step 4:An oxidative treatment further denatures persisting soluble proteins, thereby eliminating potential antigenicity.

Step 5:Freeze-drying by lyophi-lization preserves the natural structure of the tissue and maintains aresidual moisture of < 5%, allowing quick rehydra-tion and easy handling.

Step 6:Double packing and final

sterilization by gamma-irradiation guarantees a 5-year shelf-life at

room temperature.

7. Osbon DB, Lilly GE, Thompson CW, et al: Bone grafts with surface decalcified allogeneic and particulate autologous bone: Report of cases. J Oral Surg 35:276, 1977

post rad.

post proc.

Page 5: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

8 9

maxgraft®

Processed human allograft

maxgraft® is a sterile, high-safety allograft product, derived from hu-

man donor bone, processed by the Cells+Tissuebank Austria.

Mineralized collagen

The thermogravimetric analysis shows the mass reduction following

heating and helps to determine the content of water and organic

components like collagen. Heating from room temperature up to

1000°C resulted in a staged mass reduction. The first reduction

of 34.64% can be attributed to the vaporization of water and the

combustion of collagen, the second (3.88%) to the vaporization

of carbon dioxide.

For experienced oral and maxillofacial surgeons, allograft bone

blocks for block augmentation are the only real alternative to

harvesting patients‘ bone. A second surgical site to harvest autolo-

gous bone and the associated risk of infection, donor-site morbidity,

postoperative pain and loss of bone stability can be avoided. The

excellent biological regeneration capability of maxgraft® results in a

predictable clinical outcome.

SEM pictures of maxgraft® illustrate the structure of the processed bone.

Processing does not affect structural features and with its interconnecting

macroporosity, maxgraft® is natural human bone matrix. Because of the

special production process without sintering, maxgraft® retains its col-

lagen matrix. At a higher magnification the structure of the mineralized

collagen fibers can be recognized.

Properties- Preserved biomechanical properties

- Sterile without antigenic effects

- Storable at room temperature for five years

- Osteoconductive properties supporting natural

and controlled tissue remodeling

Biopsy of maxgraft® five months after implantation. The allogenic particle (P) can be recognized by the empty cavities of the osteocytes and is strewn with circular re-sorption lacunae. The particle is embedded into newly formed bone matrix (B)

The macroscopic structure of maxgraft® cancellous granules affirms the physiological constitution of the graft

The trabecular structure of cancellous bone allows optimal graft revascularization, rapid formation of new bone tissue and complete bone remodeling

Thermogravimetric curve of maxgraft® showing the staged mass reduction that indicates the chemical composition

SEM pictures of maxgraft® at a 100-fold and 5000-fold magnification, showing the macroporous structure and surface of the mineralized collagen matrix

100

95

90

85

80

75

70

65

60

0 100 200 300 400 500 600 700 800 900 1000

-34.64% water and collagen

-3.88% CO2

Temperature [°C]

Wei

ght [

%]

Indications: Implantology, Periodontology and Oral and CMF Surgery

Granules- Localized augmentation of the ridge for future implant placement

- Reconstruction of the ridge for prosthetic therapy

- Filling of osseous defects, such as extraction sockets

- Elevation of maxillary sinus floor

- Repair of intrabony periodontal defects

Blocks- A predictable and highly effective alternative to

traditional block grafting

- Ridge augmentation

B

B

P

.................................................

~70% mineral

Surface

~30% organic

Structure and tissuecomposition

Page 6: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

10 11

botiss-dental.com/products/maxgraft-bonering

maxgraft® bonering

Processed allogenic bone ring

Preparation of ring bed

After determination of the position of the implant by the planator tip and the pilot drill, the ring bed is prepared with the trephine. Subsequently, the planator allows even paving of the local bone for optimal contact with maxgraft® bonering and in addition, removes the cortical layer for improved graft revascularization.

The height of maxgraft® boneringis adjustable to the defect

Immediate implant insertion through maxgraft® bonering ensures primary stability of implant and graft

Indications:Implantology- Vertical augmentation

(in combination with

horizontal augmentation)

- Single tooth gap

- Edentulous space

- Sinus lift

Advantages

- Simultaneous implant place-

ment and bone augmentation

- No second surgical procedure

- Significant reduction of

treatment time

maxgraft® bonering is a pre-fabricated cancellous ring of human

donor bone, which is placed press-fit into a trephine drill-prepared

ring bed. At the same time, an implant is inserted into the ring. The

bony integration of both, maxgraft® bonering and the implant, occurs

via the surrounding vital bone.

The maxgraft® bonering technique allows bone aug-

mentation and implantation in a one-stage procedure.

The technique is applicable for almost all indications,

including sinus lift with limited maxillary bone height.

Compared to the classical, two-stage augmentation

with i.e. bone blocks, this technique reduces the entire

treatment period by several months and saves the re-

entry.

The maxgraft® bonering allows vertical and horizontal

augmentation and new bone formation, therefore sim-

plifying the surgical treatment.

diamond disc10 mm

trephine 7 mm

trephine 6 mm

planator 6 mm

planator 7 mm

diamond tulip3 mm

Soft tissue management

Sharp edges should be smoothened to avoid soft tissue perforation and to support wound healing. Moreover, maxgraft® bonering should be covered with a slowly resor-bable bone regeneration material (e.g. cerabone®) to fill the residual defect volume and to avoid potential adaption resorption of the graft

After covering of the graft with a colla-gen membrane (Jason® membrane) a tension-free suturing of the operation site must be assured to avoid tissue perforation and graft exposure

The maxgraft® bonering technique enables vertical bone augmentation and direct implantation

.................................................

One-stage bone augmentation and implant placement

With this surgical kit, botiss provides all necessary instruments to

apply the maxgraft® bonering technique. The kit includes two con-

venient sizes of trephines, which precisely fit together with the max-

graft® bonering diameters.

The planators allow paving of the local bone to create a congruent

and fresh contact surface of the implant area. The diamond disc

and the diamond tulip help to shape the maxgraft® bonering for

excellent adjustment to the local bone and for improved soft tissue

healing. Altogether, these instruments allow optimal preconditions

for the bony ingrowth of maxgraft® bonering.

All instruments are made of high quality surgical steel.

maxgraft® bonering surgical kit

Product Specificationsmaxgraft® bonering 3.3(Height 10 mm, recommended for implant diameters from 3.3 - 3.6 mm)

Art.-No. Dimension Content.........................................................................................................33160 cancellous ring, Ø 6 mm 1 x33170 cancellous ring, Ø 7 mm 1 x

maxgraft® bonering 4.1(Height 10 mm, recommended for implant diameters from 4.1 mm)

Art.-No. Dimension Content.........................................................................................................33174 cancellous ring, Ø 7 mm 1 x

33000 maxgraft® bonering surgical kit 1 set33010 bonering fix 1 x

bonering fix

Page 7: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

12 13

The maxgraft® bonebuilder technology

maxgraft® bonebuilder Customized allogenicbone block

The maxgraft® bonebuilder technology

www.botiss-bonebuilder.com

1. Upload of CT/DVT-data on www.botiss-bonebuilder.com

After registration, CT/DVT-data of the patient can be uploaded on

the botiss server. All radiological data have to single-frame data ima-

ges. The only data type suitable for 3D planning is DICOM (*.dcm).

2. Block designbotiss designers create a three-dimensional model of the radiolo-

gical images and design a virtual bone transplant in consultation

with the clinical user.

maxgraft® bonebuilder is a customized allogenic bone transplant,

which is individually adjusted to the bone defect. With maxgraft®

bone-builder, harvesting of autologous bone and manual adjustment

of the obtained transplant is no longer required for the treatment of

extensive defects. Donor site morbidity, operation time and costs

can be significantly reduced.

After placement, the maxgraft® bonebuilder block is fixed with os-

teosynthesis screws. Residual defect volume should be filled with

bone regeneration material and the augmentation site should be

covered with a collagen membrane.

The strong capillary action of the three-dimensional, porous

trabecular bone network enables fast and efficient penetration of

nutrients and blood, resulting in excellent handling, as well as relia-

ble and predictable outcomes.

The maxgraft® bonebuilder technology allows complex reconstruction in cases of extensive jaw atrophy

Each block is designed individually according to the defect and the desired dimension of the augmentation

3. Design quality checkThe clinical user receives a 3D PDF file containing

the virtually constructed maxgraft® bonebuilder

block and has to confirm its design.

4. Individual orderThe production of the block starts after the clinical

user fills in the patient based order form for the

bone block to the attention of botiss biomaterials.

5. Production of the individual bone blockAt C+TBA the *.stl data of the design is imported

into a milling machine and a block of maximally

23 x 13 x 13 mm is produced.

The CT/DVT-data of the bone defect is transfered into a 3D model

Based on this model botiss designs a virtual block, which matches the surface structure of the defect and allows stable implant insertion after augmentation

The customized maxgraft® bonebuilder block allows precise horizontal and vertical reconstruction of the atrophic ridge

In-house planningbotiss virtually designs the patient customizedallogenic bone

transplant based on the CT/DVT-scan of the bone defect. The

design of the bone transplant undergoes a final inspection by the

clinical user and is, by individual order, released for production. The

botiss partner Cells+Tissuebank Austria receives a *.stl milling file

and the patient matched allogenic bone transplant is produced

under cleanroom conditions. The resulting bone block is ready for

insertion into the defect with only minor adjustments.

Indications- Extensive bone defects

- Atrophic maxilla/mandibula

- Horizontal/vertical

augmentation

Advantages- Individualized allogenic bone

transplant

- Significantly reduced operation

time

- Improved wound healing

maxgraft® bonebuilder

Art.-No. Content........................................................................................................PMIa Individual planning and production of a bone transplant max. dimensions 23 x 13 x 13 mmPMIa 2 additional block(s) for this patient

Product Specifications

Page 8: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

14 15

www.botiss.com

maxgraft® corticoShell technique with allogenic bone plates

Preparation of the augmentation area

maxgraft® cortico is a prefabricated plate made of processed allogenic bone. Similarly to

the autogenous bone, it can be used for the shell technique.

maxgraft® cortico was developed to avoid the donor-site morbidity and to prevent the

time-consuming harvesting and splitting of autologous cortico-cancellous bone blocks.

The proper size of the plate is estimated after the elevation of the mucosal flap or preoperatively using

a digital planning software. Using a diamond disc, the plate is then cut extraorally.

Augmentation of a frontal mandibular defect

The plate is positioned within a certain distance by predrilling through the plate and local bone; fixation is

performed with osteosynthesis screws to create a fixed compartment. To prevent the perforation of the soft

tissue, the sharp edges has to be removed, e.g., by using a diamond ball.

Indications:

- Vertical augmentation

- Horizontal augmentation

- Complex three-dimensional

augmentations

- Single tooth gaps

- Fenestration defects

Properties- Osteoconductive

- Natural and controlled remodelling

- Conserved biomechanical parameters

- Steril, no antigenic effect

- Five-year shelf life

Fixation and adaption Advantages

- Established augmentation technique with new

material

- Significant reduction of operation time

- No donor-site morbidity

- No limitation of augmentation material

Filling and wound closure

maxgraft® cortico..............................................

The shell techniquewith maxgraft® cortico

The space between local bone and cortical plate can be filled with a variety of different particulated bone

grafting materials. Then, the augmentation area needs to be covered with a barrier membrane (Jason®

membrane, collprotect® membrane) and a tension-free and saliva-proof closure must be applied.

Product Specificationsmaxgraft® cortico

Art.-No. Dimension Content.........................................................................................................31251 cortical strut, 25 x 10 x 1 mm 1 x31253 cortical strut, 25 x 10 x 1 mm 3 x 1

cortico trimmer

Art.-No. Content.........................................................................................................34000 cortico trimmer 1 x Natural bone regeneration

To facilitate osteogenesis, allogenic particles can

be used to fill the defect. The preserved human

collagen provides an excellent osteoconductivity

and enables a complete remodelling. Mixing with

autologous chips or particulated PRF matrices

can support the ossification.

Six months after transplantation, a superfi-cial resorption of the plate can be seen; the stability, however, is maintained

Page 9: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

16 17

Clinical application

Clinical case by Dr. Fernando Rojas-Vizcaya, Castellón, SpainSocket preservation with maxgraft® granules

Mobilization and pre-fixation of

the surrounding soft tissue

Clinical situation in the maxilla

before extraction

Clinical situation four months

post-operative

Situation after tooth extraction

and mobilization of mucosal flap

Maxillary ridge in situ after pre-

paration of mucosal flap

Tension-free wound closure

Augmentation of the maxillary ridge and

filling of extraction sockets with max-

graft® granules. Placement of mucoderm®

to improve soft tissue situation and

Jason® membrane to cover surgical site

Insertion of four implants Placement of abutments Positioning of prosthesis Closure of mucosal flap

After immediate loading proto-

col: Prosthesis will guide soft tis-

sue during healing process

Four months post-operative:

Bone is at the level of the

planned crowns

Antibiotics When performing hard tissue augmentation, the patient

should be treated with a sufficient dose of antibiotics to mini-

mize the risk of infection and related possible graft loss. A po-

tential treatment plan could include starting the antibiosis one

day prior or at least one hour before surgery by ingestion of a

full daily dose. In case of extensive jaw reconstruction a bac-

teriological screening (saliva sample) should be considered.

Clinical application

Clinical case by Dr. Damir Jelušic, Opatija, Croatia

Ridge augmentation with maxgraft® cancellous blocks

Atrophic maxillary ridge after

preparation of mucosal flap

Filling of residual gaps with

cerabone® and covering with

Jason® membrane

Tension-free closure of muco-

sal flap

X-ray and CAD/CAM-based 3D image of maxillary ridge before

surgery

Manual adjustment of max-

graft® blocks on a CAD/CAM-

based model

Clinical situation

Fixation of the prepared max-

graft® blocks

CAD/CAM-based 3D image

three days post-operative

Six months after re-entry: Patient

is ready for final prosthesis

Clinical situation five months

post-operative

X-ray five months post-

operative

Insertion of three implants and

gingiva formers

GBR/GTRResorbable collagen membranes act as a temporary barrier against ingrowth of fast proliferating

fibroblasts and epithelium into the defect, and maintain the space for controlled regeneration of

bone. The Jason® membrane is a pericardium membrane providing a long-lasting barrier function

for ~three to six months. mucoderm®, a three-dimensional collagen matrix, supports revasculariza-

tion and fast soft tissue integration and thus, is a valid alternative to patients’ own connective tissue.

When applying mucoderm® simultaneously with a bone graft material please assure adequate

mobilization of the surrounding soft tissue.

Page 10: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

18 19

Clinical application

Clinical case by Dres. Bernhard Giesenhagen and Orcan Yüksel, Frankfurt, GermanyPart I: Vertical augmentation with maxgraft® bonering

Stable implant insertion Insertion of second maxgraft®

bonering and implant

Preparation of the ring bed in

an atrophic mandibula (third

quadrant)

Vertical augmentation by

placing a maxgraft® bonering

Simultaneous horizontal

augmentation

Filling of the residual defect

volume with cerabone® and

covering the operation site with

a Jason® membrane

Tension-free soft tissue manage-

ment

Vertical augmentation with maxgraft® bonering For the reconstruction in an atrophic jaw a vertical augmentation

of up to 3 mm above local bone level can easily be achieved.

If more vertical height is desired, enhancing additives such as

bone morphogenic proteins (BMP) or growth factors are in dis-

cussion to be beneficial. For vertical and horizontal augmentation

of a severely atrophic mandibular, the width of the ridge (in case

of parallel-walled ridge) has to be at least 4mm for successful

application of maxgraft® bonering.

The maxgraft® bonering allows for direct implant insertion during

sinus lift by providing the necessary primary stability. The sinus

cavity should be filled with an additional grafting material (e.g.

cerabone®, maxresorb® or maxresorb® inject).

Clinical application

Part II: Sinus lift with maxgraft® bonering

Placement of maxgraft®

bonering

Filling of the residual sinus cavity

with cerabone®

Placement of Jason®

membrane

Preparation of a lateral window

for sinus floor elevation in the

first quadrant

Mobilization of the Schneiderian

membrane

Insertion of the first implant

Implant insertion in maxgraft®

bonering from the crestal side

Clinical situation in the second

quadrant: Vertical and horizontal

defect in the maxillary ridge; sinus

cavity is filled with cerabone®

Preparation of the defect with

a trephine

Press-fit placement of

maxgraft® bonering into the

defect

Direct implantation in the

cancellous ring

X-ray nine months post-operative: Full integration of maxgraft®

bonering and implants and proceeding remodeling of the grafts

Tension-free suturing after place-

ment of Jason® membrane

RehydrationThe processing of maxgraft® products preserves the natural collagen

content of the bone tissue and a residual moisture of ~5%. Thus, the

products don‘t have to be re-hydrated but are ready for instant use.

Be aware that excessive hydration can result in the loss of structural

integrity!

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20 21

Clinical application

Clinical case by Dr. Darius Pocebutas, Kaunas, Lithuania

Horizontal augmentation in a single tooth gap with maxgraft® bonering

Pilot drill in the recipient siteClinical situation pre-operative

Due to its structure the ring is

instantly soaked with blood

Preparation of the ring bed with

the trephine

Tension-free wound closureImplant insertion in maxgraft®

bonering; the shape of the ring

mimics the anatomic structure

of the ridge

Adjustment of maxgraft®

bonering to desired height

Measurement of the defect

Paving of the local bone using

the planator from maxgraft®

bonering surgical kit

Gaps are filled with cerabone®

and the augmentation site is

covered with a Jason® mem-

brane

Placement of the ring into the

ring bed

Graft exposureWound dehiscence and graft exposure can be

complications of block augmentation.

After removal of necrotic soft tissue and infected

hard tissue (use rotating instruments if necessary)

the augmented area should be rinsed with chlor-

hexidine. Subsequently, the graft has to be co-

vered again, if necessary, by harvesting a palatal

soft tissue transplant.

Clinical application

Clinical case by Dr. Anke Isser, Frankfurt, Germany

Ridge augmentation with maxgraft® bonebuilder

Perfect fit of maxgraft®

bonebuilder

Fixation of the blocks with

screws for osteosynthesis

Contouring with cerabone®

Clinical situation pre-operative Midcrestal incision line Lingual mobilization and cortical

perforation

Covering of the block with

Jason® membrane

Horizontal matress suture and

tension-free wound closure

Design quality check The design of maxgraft® bonebuilder has to be checked very carefully before it is

released for production. Only the surgeon himself can assess the patients‘ soft

tissue situation and therefore, the required dimensions of the block. The botiss

construction team will adjust the design of the block until it perfectly meets the

expectations of the clinician.

Page 12: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

22 23

Clinical application

Clinical case by Dr. Michele Jacotti, Brescia, Italy

Ridge augmentation with maxgraft® bonebuilder

Fixation of the block with screws

for osteosynthesis

Clinical situation at re-entry five

months post-operative

Full bony ingrowth of the block

Virtual planning of the block Patient matched maxgraft®

bonebuilder

Situation after mucosal flap

preparation and perforation of

the cortical layer

Exact positioning of the max-

graft® bonebuilder block

Careful wound closure

3D implant positioning Stable implant insertion Abutment placement after

ingrowth of the implants

Final prosthesis

Clinical application

Clinical case by Dr. Viktor Kalenchuk, Chernivtsi, Ukraine

Ridge augmentation with maxgraft® bonebuilder

maxgraft® bonebuilder

Clinical situation before

augmentation

Covering of the augmentation

site with collprotect® membrane

CT scan of region 36, 37 before

surgery

Wound closure and suturing

Immediate implant insertion in

regio 34, 35; positioning and

fixation of maxgraft® bonebuilder

Filling of residual volume with

cerabone®

Situation after tooth extraction

and mobilization of mucosal

flap

CT scan of region 36, 37 after

surgery

Fixationmaxgraft® blocks are fixed with screws for osteosynthesis,

preferably with flat-headed screws to avoid perforation of the

surrounding soft tissue.

Page 13: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

24 25

+ +

+ +

+++

cerabone®

Jason® membranehard tissue Guided bone regeneration

Shell techniqueRidge preservationmaxgraft® bonebuilder concept

Recession coverage Peri-implant soft tissue thickening

Immediate implantation

soft tissue

Rehydration The processing of the C+TBA

products preserves the na-

tural collagen and maintains

a residual moisture of <5%.

According to our clinical users

rehydration is not necessary

and the products are ready for

immediate use.

Covering of the augmentation

area with Jason® membrane

Tension-free wound closure

Augmentation with cerabone®

Situation after a healing period

of four and a half months

Covering with Jason® memb-

rane and saliva-proof wound

closure

Single tooth defect with se-

verely resorbed vestibular wall

Severe atrophy in the esthetic

region

Fixation of maxgraft® cortico

using an osteosynthesis screw

Preparation of the defect

Augmentation with maxgraft®,

granules mixed with particula-

ted PRF matrizes and fixation

of a second maxgraft® cortico

maxgraft® cortico in

preparation

Covering with a PRF matrix for

improved soft tissue healing

Fixation with osteosynthesis

screws

Stable implantation

Clinical application

Clinical case Jan Kielhorn, Oehringen, Germany

Frontal defect treated with maxgraft® cortico

Clinical case Dr. Krzystof Chmielewski, Gdansk, Poland

Single tooth restauration with maxgraft® cortico

indication-matrix.com

cLinicaL SUccESSwith the right

regeneration concept

Live-webinarinteract and exchange in real time with our

internationally renowned speakers on current

topics regarding tissue regeneration.

On-Demand Coursesall webinars are free of charge and can be

accessed online at any time after the live-

broadcast.

CE creditsEach webinar participant is credited with

1 CE. The certificate can be downloaded

and printed immediately after attending

the webinar.

www.botiss-webinars.com Find more on:

Jan KielhornCortical struts and computer aided bone augmentation

Krzysztof chmielewskiGBR in my daily practice: tent technique, cortical struts, maxgraft® bonebuilder, xenograft, PRF and more - selection of materials and techniques to achieve best results

Bernhard GiesenhagenThe bone ring technique - new perspectives in augmentation

Knowledge is online

Page 14: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

26 27

maxgraft®

Product Specifications

Product Specificationsmaxgraft® cancellous granules

Art.-No. Particle Size Content....................................................................30005 < 2.0 mm 1 x 0.5 ml 30010 < 2.0 mm 1 x 1.0 ml30020 < 2.0 mm 1 x 2.0 ml30040 < 2.0 mm 1 x 4.0 ml

maxgraft® cortico-cancellous granules

Art.-No. Particle Size Content....................................................................31005 < 2.0 mm 1 x 0.5 ml31010 < 2.0 mm 1 x 1.0 ml31020 < 2.0 mm 1 x 2.0 ml31040 < 2.0 mm 1 x 4.0 ml

maxgraft® bonering

maxgraft® blocks

Art.-No. Dimension Content....................................................................31111 uni-cortical 1 x block 10 x 10 x 10 mm31112 uni-cortical 1 x block 20 x 10 x 10 mm 32111 cancellous 1 x block 10 x 10 x 10 mm 32112 cancellous 1 x block 20 x 10 x 10 mm

Product SpecificationsArt.-No. Content...................................................................................................... PMIa Individual planning and production of a bone transplant max. dimensions 23 x 13 x 13 mmPMIa2 additional block(s) for the same patient

Product SpecificationsArt.-No. Particle Size Content...................................................................................................... 31251 25 x 10 x 1 mm 1 x31253 25 x 10 x 1 mm 3 x 1

Product Specifications

maxgraft® bonering 3.3(Height 10 mm,recommended for implant diameters from 3.3 - 3.6 mm)Art.-No. Dimension Content.........................................................................................................33160 cancellous ring, ø 6 mm 1 x33170 cancellous ring, ø 7 mm 1 x

maxgraft® bonering 4.1(Height 10 mm, recommended for implant diameters from 4.1 mm)Art.-No. Dimension Content.........................................................................................................33174 cancellous ring, ø 7 mm 1 x

maxgraft® bonebuilder maxgraft® cortico

Product SpecificationsArt.-No. Content....................................................................33000 1 x trephine 7 mm 1 x trephine 6 mm 1 x planator 7 mm 1 x planator 6 mm 1 x diamond disc 10 mm 1 x diamond tulip 3 mm

maxgraft® bonering surgical kit Product SpecificationsArt.-No. Content....................................................................33010 bonering fix

bonering fix

maxgraft® bonebuilder dummyArt.-No. Content..................................................................32100 Individual 3D-printed model of the patient`s defect and the planned bonebuilder for demonstration purposes made of plastic

cortico trimmerArt.-No. Content.........................................................................................................34000 cortico trimmer 1 x

Page 15: botiss - indication-matrix.com · Hiatt WH, Schallhorn RG.Intraoral transplants of cancellous bone and marrow in periodontal lesions. J Periodontol. 1973 Apr;44(4):194-208. 2. Dragoo

28

botissbiomaterials

bone & tissue regeneration

soft tissue

education

hard tissue

botiss biomaterials GmbH

Hauptstr. 28

15806 Zossen / Germany

Tel.: +49 33769 / 88 41 985

Fax: +49 33769 / 88 41 986

[email protected]

www.botiss.com

www.botiss-dental.com

Innovation.

Regeneration.

Aesthetics.

Rev.: MGen-06/2017-01